Going beyond clinical trials in the era of real world data
SP-0520
Abstract
Going beyond clinical trials in the era of real world data
Authors: Catherine Fortpied1
1EORTC, Biostatistics, Brussels, Belgium
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Abstract Text
In this talk, two currently ongoing EORTC studies in the OligoMetastatic research area will be used to discuss the differences, the advantages and limitations of prospective observational studies versus randomized controlled trials (RCT), from a methodological perspective :
• EORTC-ESTRO E2-RADIatE - OligoCare: A pragmatic observational cohort study to evaluate radical radiotherapy for oligo-metastatic cancer patients,
• EORTC OligoRare : Stereotactic body radiotherapy in addition to standard of care treatment in patients with oligometastatic rare cancers: a randomized, phase 3, open-label trial.
Where traditional clinical trials may be difficult to conduct due to feasibility or ethical issues, combining real-world and clinical trial data can be valuable to generate evidence. We will present “pragmatic” study designs such as Registry-based RCTs or Cohort multiple RCTs (now known as TWICs).